# Ostial Corporation

- Location (FDA's records): Mountain View, CA
- FDA decisions: 12 (2011–2016): 12 510(k) clearances
- Product codes: LIT (6), LOX (5), FGE (1)
- Predicates its devices cite: 19 (15 its own); citations of its devices by later devices: 16 (15 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Scimed Life Systems, Inc.: 1 (https://510kreport.com/company/scimed-life-systems)
- Squareone: 1 (https://510kreport.com/company/squareone)

## Firms that cite its devices most
- Verge Medical, Inc.: 1 (https://510kreport.com/company/verge-medical)

## Its most-cited devices
- K120738: Flash Pta Balloon Dilatation Catheter-4.0X14MMX135CM (2012), cited by 3
- K111284: Flash-C Ptca Balloon Dilation Catheter - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM (2011), cited by 2
- K121175: Flash Pta Ballon Dilatation Catheter-5MM X 19MM X 135CM (2012), cited by 2
- K113775: Flash-C Ptca Balloon Dilatation Catheter- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM (2012), cited by 2
- K102482: Flash Pta Balloon Dilatation Catheter 5MM X 19MM X 135CM; Flash Pta Balloon Dilatation Catheter 6MM X 19MM X 135CM (2011), cited by 2
- K133861: Flash Ostial System Otw-7.0MMX17MMX135CM, Flash Ostial System Otw-7.0MMX17MMX80CM (2014), cited by 1

## Recent decisions
- K152485: FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm (Feb 16, 2016)
- K150946: FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm (May 8, 2015)
- K133861: Flash Ostial System Otw-7.0MMX17MMX135CM, Flash Ostial System Otw-7.0MMX17MMX80CM (Jul 2, 2014)
- K131450: Flash Mini Ostial System - 3.0MM X 135CM, Flash Mini Ostial System - 3.5MM X 8MM X 135CM, Flash Mini Ostial System - 4.0 (Aug 6, 2013)
- K122178: Flash-C Ptca Balloon Dilatation Catheter - 4MM X 14MM X 135CM, Flash-C Ptca Balloon Dilatation Catheter - 4MM X 19MM X 1 (Oct 11, 2012)
- K122379: Flash Pta Balloon Dilatation Catheter - 4MM X 14MM X 135CM, Flash Pta Balloon Dilatation Catheter - 4MM X 19MM X 135CM (Sep 5, 2012)
- K121175: Flash Pta Ballon Dilatation Catheter-5MM X 19MM X 135CM (Jun 29, 2012)
- K113582: Archstent Biliary System (Jun 29, 2012)

Source page: https://510kreport.com/company/ostial